pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinesterase Inhibitors.

Cholinesterase

Indications

Sourced from openFDA
  • OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.ICD-10: B85.0

Contraindications

Sourced from openFDA
  • OVIDE Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. OVIDE Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.contraindicated

Dosage & administration

Sourced from openFDA

Apply OVIDE Lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying OVIDE Lotion. Wash hands after applying to scalp. Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered. After 8 to 12 hours, the hair should be shampooed. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs. If lice are still present after 7 - 9 days, repeat with a second application of OVIDE Lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Warnings & precautions

Sourced from openFDA

OVIDE Lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. OVIDE Lotion should only be used on children under the direct supervision of an adult. If OVIDE Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the OVIDE Lotion, and if irritation reoccurs, consult a physician. Chemical burns including second-degree burns and stinging sensations may occur with the use of OVIDE Lotion. General Keep out of reach of children. Close eyes tightly during product application. If accidentally placed in the eye, flush immediately with water. Use only on scalp hair. Information to Patients OVIDE Lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. The person applying OVIDE Lotion should wash hands after application. Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. OVIDE Lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.

Adverse reactions

Sourced from openFDA

Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis. It is not known if OVIDE Lotion has the potential to cause contact allergic sensitization.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category B There was no evidence of teratogenicity in studies in rats and rabbits at doses up to 900 mg/kg/day and 100 mg/kg/day malathion, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding malathion up to 2,500 ppm (~ 200 mg/kg/day) in the diet during a three - generation evaluation period. These doses were approximately 40 to 180 times higher than the dose anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability). Because animal reproduction studies are not always predictive of human responses, this drug should be used (or handled) during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle. Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution. Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion. Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.

Approval history

Sourced from openFDA
  • May 23, 2012ANDAANDA091559Suven Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
98 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1212%
  2. 2Pain1111%
  3. 3Alopecia99.2%
  4. 4Vomiting88.2%
  5. 5Drug Exposure During Pregnancy77.1%
  6. 6Dyspnoea77.1%
  7. 7Pregnancy With Injectable Contraceptive77.1%
  8. 8Thermal Burn77.1%
  9. 9Burns Second Degree55.1%
  10. 10Diarrhoea55.1%
  11. 11Abdominal Pain44.1%
  12. 12Application Site Burn44.1%
  13. 13Application Site Scab44.1%
  14. 14Application Site Vesicles44.1%
  15. 15Blister44.1%

Literature

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Recent PubMed references pinned to Malathion as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Malathion as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Malathion work?
Mechanism-of-action class: Cholinesterase Inhibitors.
What is Malathion used for?
According to FDA labeling, Malathion carries indications including: OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Malathion?
Malathion is classified as Other ectoparasiticides, incl. scabicides, Cholinesterase Inhibitor, Cholinesterase Inhibitors, Increased Acetylcholine Activity.
What are the brand names for Malathion?
Malathion is marketed under brand names including Ovide.
What are the contraindications for Malathion?
Malathion labeling lists contraindications including: OVIDE Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. OVIDE Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.. Always consult the full prescribing information and a clinician.
Note. Data for malathion is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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